RESUMO
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).
RESUMO
In the present study, we provide evidences for a differential effect of perinatal alcohol exposure with a direct correlation to the genetic background on the development of seizures. Ethanol (EtOH) is a widely used psychoactive substance that exerts its action by affecting multiple targets in the central nervous system. EtOH is known to interact with almost all identified neurotransmitters although its effects on excitatory and inhibitory amino acid neurotransmissions are considered to be particularly important in the mediation of its behavioural effects. Prenatal exposure to alcohol is associated with a wide variety of offspring's abnormalities which lead to the so called foetal alcohol syndrome (FAS), which is also related to a higher susceptibility to convulsions. In our study, a rat strain of convulsive epilepsy, the GEPRs rats, displayed an increase of seizure susceptibility after foetal exposure to this teratogenic drug, while a non-convulsive rat strain of absence epilepsy, the WAG/Rij rat, did not fully develop its characteristic features. However, when all groups of rat where tested for pentyletetrazole-induced convulsion, animals perinatally treated with ethanol were less responsive in comparison to their respective controls. These results are in agreement with previous reports showing how the genetic background can directly influence the teratogenic effects of alcohol, and this can be strictly related to the variability in the observation of offspring anomalies in humans which has lead to a 5-category classification system for individuals exposed to alcohol in uterus.
